FDA Registration
Active
🇺🇸 United States
butterflyBVM
Reg #: 3038430561
·
FEI: 3038430561
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Compact Medical Inc.
- Registration Number
- 3038430561
- FEI Number
- 3038430561
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 525 South Meridian St., Suite 2D2
- City
- Indianapolis
- State
- IN
- ZIP
- 46225
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243861
Owner / Operator
- Firm Name
- Compact Medical Inc.
- Operator Number
- 10093438
- Address
- 7711 Ashtree Drive
- City
- Indianapolis
- State
- IN
- Postal Code
- 46259
- Country
- US
- Correspondent
- Jonathan Merrell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2025-05-15 |
Proprietary Names
butterflyBVM
ButterflyBVM
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility